Evaluation of a Point-of-care Lateral Flow Assay in Glial Fibrillary Acidic Protein (GFAP) and D-dimer in Diagnosis of Large Vessel Occlusion Acute Ischemic Stroke in a Pediatric Hospital

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07474675
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Point of Care Rapid Assay — DEVICE
    In this study, participants will provide a small sample of blood to test the accuracy and efficacy of the Rapid Assay device. Standard of care for diagnosis will follow, regardless of Assay outcomes.

Study Details

The goal of this study is to test the efficacy of a rapid bedside blood test in determining if a stroke is happening in children who present to the emergency department with stroke symptoms. The main questions it aims to answer are: * To determine the sensitivity of detecting a large vessel occlusion (LVO) as the etiology of acute ischemic stroke (AIS) in a pediatric population using a point-of-care blood-based assay (LVOne). * To determine the positive predictive value (PPV) of LVOne in a pediatric population Participants will: * Provide a small sample of blood to be used to test the accuracy of the device. * Participants will still receive all standard of care work-up for stroke, which could include computed tomography/magnetic resonance imaging (CT/MRI).

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Stroke code patients in BCH ED
    Any patient who presents to Boston Children's Hospital (BCH) Emergency Department (ED) and whose clinical evaluation justifies activation of a stroke code will be considered. Once identified, inclusion/exclusion criteria will be evaluated and if terms are satisfied, patient will be approached for consent.

Primary Outcome Measure

Sensitivity of Device [ Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Adam Porter, MPH
[email protected]
617-919-6013
Rebekah Mannix, MD, MPH (SUB_INVESTIGATOR)
Laura Lehman, MD, MPH (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Boston Children's Hospital· Boston, MA

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